For US residents only.
Ph+ CML is a cancer of the blood and bone marrow.
Blood is made up of 3 cells: white blood cells, red blood cells, and platelets. Leukemia [loo-key-mee-ah] is a disease that makes your white blood cells grow abnormally and out of control. As leukemia spreads, diseased cells take over the healthy ones. This can make you feel very sick.
Over time, leukemia cells can spread to the rest of your blood and other organs. When this happens, other cells in your body may stop working the way they should.
A main goal of treating Ph+ CML is to reduce the number of leukemia cells in your body. Doctors use medicine to lower the amount of leukemia in your blood.
It’s important to take an active role in your care. You can do this by taking your medicine the way your doctor tells you. You should also get regular tests to check how the medicine is working.
Ph+ CML happens when an abnormal gene called BCR-ABL1 produces an abnormal protein, also called BCR-ABL1. The BCR-ABL1 protein sends a signal that creates leukemic cells in the blood and bone marrow.
During in vitro studies, meaning studies that were conducted in test tubes, TASIGNA® (nilotinib) was shown to bind to and stabilize the inactive formation of the ABL1 protein. This blocked the signal that leads to the production of leukemic cells.
Blocking the signal may reduce the amount of leukemic cells and allow healthy blood cells to grow.
The connection between TASIGNA in vitro data and its effectiveness has not been established.
PCR testing is an accurate way for doctors to measure how much BCR-ABL1 is in your body. PCR blood testing can find very small amounts of BCR-ABL1 that other tests cannot find.
PCR is a simple blood test, rather than a bone marrow test. However, doctors still must do bone marrow testing to diagnose Ph+ CML.
TASIGNA may cause side effects in some patients. Some of these side effects are serious, and some are more common.
What is the most important information to know about prescription TASIGNA?
TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation.
TASIGNA may cause serious side effects including:
Your doctor may do blood tests to check you for TLS
Most patients experience side effects at some time. Some common side effects you may experience include:
Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Take TASIGNA on an empty stomach:
Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA. Food and grapefruit products increase the amount of TASIGNA in your body.
Avoid taking other medicines or supplements with TASIGNA that can also cause QTc prolongation.
TASIGNA can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.
Do not take any other medicine while taking TASIGNA unless your healthcare provider tells you it is okay to do so.
If you cannot swallow TASIGNA capsules whole, you may open the TASIGNA capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce (puréed apple). Swallow the mixture right away (within 15 minutes).
For more information, see “How should I take TASIGNA?”
Call your healthcare provider right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QTc prolongation.
Your health care provider may change your dose. Your health care provider may have you stop TASIGNA for some time or lower your dose if you have side effects with it.
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The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. The NCCN Guidelines® are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.